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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; TRACHEOSTOMY
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SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; TRACHEOSTOMY Back to Search Results
Model Number 9.0 MM
Device Problem Gas/Air Leak (2946)
Patient Problem Low Oxygen Saturation (2477)
Event Date 02/27/2021
Event Type  Injury  
Event Description
Information received a smiths medical tracheostomy|pvc - portex tubes pdt uniperc an unplanned trach change was needed due to a leak, issue appeared to be related to positioning of tube.It was reported the patient was intubated orally and trache tube removed.Then inserted a new 9.0 uniperc adjustable flange trache (checked for leaks prior to insertion) cuff pressure checked 32cm h20 pressure.Prior to this it was reported the trache stoma was made larger by trimming 3rd tracheal ring.
 
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Brand Name
PORTEX
Type of Device
TRACHEOSTOMY
Manufacturer (Section D)
SMITHS MEDICAL INTERNATIONAL, LTD.
olomoucka 306
hranice 1, mesto 753 0 1
EZ  753 01
MDR Report Key11646859
MDR Text Key244843613
Report Number3012307300-2021-03053
Device Sequence Number1
Product Code BTO
UDI-Device Identifier15019315107214
UDI-Public15019315107214
Combination Product (y/n)N
PMA/PMN Number
K083031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial
Report Date 04/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number9.0 MM
Device Catalogue Number100/897/090CZ
Device Lot Number3845495
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/12/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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